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Part 2 without food
Part 2 without food is a Small molecule drug developed by Klotho Sciences Australia Pty Ltd.. It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Part 2 without food |
|---|---|
| Sponsor | Klotho Sciences Australia Pty Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Diarrhoea
- Nasopharyngitis
- Headache
- Upper respiratory tract infection
- Syphilis
- Pharyngitis
- Vitamin D deficiency
- Back pain
- Insomnia
- Bronchitis
- Influenza
- Gastroenteritis
Key clinical trials
- A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 ) (PHASE3)
- A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels, and Participants With Dyslipidemia (PHASE1)
- Whey Protein Supplementation and Serum Mineral Status in Elite Endurance and Power Athletes (NA)
- Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 (PHASE2, PHASE3)
- A Multicenter Clinical Study of Combined Therapy for Unresectable Hepatocellular Carcinoma (PHASE1, PHASE2)
- Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance (PHASE2, PHASE3)
- Safety and Effectiveness of Overripe Banana Powder Added to Diabetic Formulas in Type 2 Diabetes (NA)
- A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Part 2 without food CI brief — competitive landscape report
- Part 2 without food updates RSS · CI watch RSS
- Klotho Sciences Australia Pty Ltd. portfolio CI
Frequently asked questions about Part 2 without food
What is Part 2 without food?
Who makes Part 2 without food?
What development phase is Part 2 without food in?
What are the side effects of Part 2 without food?
Related
- Manufacturer: Klotho Sciences Australia Pty Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing